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Abx464
Ulcerative Colitis
Phase III
Recruiting
ABTECT - Maintenance
Sep 07, 2022
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Abx464
Ulcerative Colitis
Phase III
Completed
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
Aug 17, 2022
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Abx464
Ulcerative Colitis
Phase III
Completed
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Aug 17, 2022
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Abx464
Ulcerative Colitis
Phase II
Active Not Recruiting
Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Dec 15, 2021
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Abx464, Caffeine, Fluvoxamine
Healthy
Phase I
Completed
Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464
Oct 11, 2021
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Abx464
Healthy Volunteers
Phase I
Completed
Safety and Pharmacokinetics Study in Healthy Japanese Volunteers
Aug 30, 2021
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Abx464
Covid-19
Phase II/III
Terminated
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
May 18, 2020
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Abx464
Rheumatoid Arthritis
Phase II
Completed
Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
Aug 06, 2019
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Abx464
Ulcerative Colitis
Phase II
Completed
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
Jul 05, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Abivax SA (ABVX) have in its pipeline
ABVX is currently developing the following drugs: Obefazimod, Abx464, Abx464. These drug candidates are in various stages of clinical development as the company works toward FDA approval.